id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ihlr-16471	Meek, Travis P.	Proper Preemption or Contrived Construction?: Why Section 360k(a) of the FDCA Should Not Be Interpreted to Preempt State Common Law Tort Claims	2006	32	.pdf	application/pdf	15164	801	59	TORT CLAIMS Travis P. Meek• INTRODUCTION Pursuant to Section 360k(a) of the Federal Food, Drug, and Cosmetic Act, a state may not impose requirements on a medical device that are different from, or in addition to, the requirements already imposed upon the device by the Federal Food and Drug Administration (FDA).1 While this express preemption provision may appear straightforward on its face, a question remains regarding its effect on state common law tort claims, such as negligence and strict liability, when the device in question has been approved through the FDA's rigorous pre-market approval process. Several courts, such as the Third, Seventh, and Ninth Circuit Courts of Appeals, have concluded that state common law tort claims involving federally approved medical devices are expressly preempted by Section 360k(a) because they represent an attempt to impose state requirements upon medical devices that are different from, or in addition to, federal requirements.	cache/ihlr-16471.pdf	txt/ihlr-16471.txt